The facility in Spain produces only the FDA-approved excipient meglumine, ensuring continuous supply to customers
Merck meglumine manufacturing plant, Spain
Science and technology company Merck has announced the opening of a facility manufacturing meglumine in Mollet des Vallès.
Meglumine is an amino sugar derived from glucose. It is an excipient for pharmaceuticals and a component of medical imaging contrast media. The FDA-validated facility is the only location in Europe that manufactures the substance.
The facility is solely dedicated to the production of meglumine, as well as meeting increasing demand for the excipient. Meglumine interacts directly with active pharmaceutical ingredients to increase solubility.
The manufacture of meglumine must meet the same stringent regulatory and quality requirements as APIs.
It is particularly important that meglumine be manufactured in a high-quality, ICH Q7-compliant facility. The facility has been successfully audited by the FDA, as well as pharmaceutical companies.
“Our new facility was optimised around the manufacturing process to achieve greater efficiencies and meets the most stringent quality standards for manufacturing meglumine,” said Andrew Bulpin, Head of Process Solutions Strategic Marketing & Innovation, Life Science. “The result is a high level of confidence in quality and security of supply for our customers.”